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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Ocean Deep, LLC 11-Apr-06

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

555 Winderley PI., Ste. 200
Maitland, FL 32751



HAND DELIVERY

WARNING LETTER

FLA-06-16

April 11, 2006

Victor Perez, Manager
Ocean Deep, LLC
1800 NtiV 96 Avenue
Miami, Florida 33172

Dear Mr. Perez :

We inspected your seafood importer establishment, located at 1800 NW 96 Avenue on February 15-16, 2006. We found that you have a serious violation of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12. As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. In accordance with 1 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4) and will be denied entry. Because our inspection identified a serious violation of 21 CFR Part 123, your fresh Mahi is adulterated under Section 402(a)(4)of the Act (21 U.S.C. § 342(a)(4)), in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.

Your significant violation is as follows:

1. You must implement an affirmative step which ensure that the fish and fishery products you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm did not perform an affirmative step for fresh Mahi manufactured by [redacted]. In addition, written product safety specifications that are designed to ensure that the fish and fishery products you import are not injurious to health are required by 21 CFR 123.12(a)(2)(i). However, your firm does not have any written product safety specifications for fresh Mahi imported by your firm from Mexico.

We may take further action if you do not promptly correct this violation. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on "detention without physical examination," seize your product(s) and/or enjoin your firm from further violating the Act.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation, such as HACCP and importer verification records and records that document the performance and results of your firm's affirmative steps, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

This letter may not list all the violations at your facility. You are responsible for ensuring that your seafood importer establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the fish or fishery products that you import into the United States.

Please send your reply to the Food and Drug Administration, Attention: Virginia L. Meeks, 555 Winderley Place Suite 200 Maitland, FL 32571. If you have questions regarding any issues in this letter, please contact Ms. Meeks at (407) 475-4731.

Sincerely,
/s/.
Kathleen M. Sinninger for Emma R. Singleton
Director, Florida District